IBD Audit on Fertility, Pregnancy and Delivery in Patients With Inflammatory Bowel Disease: a International Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Fertility
研究概览
简要总结
Crohn's disease and Ulcerative colitis are chronic disease that are usually diagnosed at young age. The diseases and the associated treatment can impact on patient's sexual function, fertility, pregnancy, and delivery. This study aims to assess the impact of inflammatory bowel diseases on these aspects in female patients.
详细描述
This is a cross-sectional, international, multicentre study. Female patients diagnosed with inflammatory bowel diseases (Crohn's disease and ulcerative colitis) treated at several Italian centres will be retrospectively assessed for inclusion.
Those who underwent surgery below the age of 35 years between 2000 and 2020 will be included. The study aims to obtain information on female fertility, pregnancy and delivery, and to identify factors associated with infertility and problems to conclude the pregnancy.
For each nation, at least one centre will collect data on patients who were not treated with surgery.
Patients who meet inclusion criteria will be asked to prospectively fill a questionnaire on fertility and pregnancy.
Data on treatments and demographic will be retrospectively collected by the local investigators and uploaded on a secure online database.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Crohn's disease diagnosis
- •ulcerative disease diagnosis
- •operated on before 36 years of age
排除标准
- •younger than 18 years old at follow-up
- •no definitive diagnosis
- •no surgical procedures performed
- •A subgroup of patients who did not undergo surgery will be used, at least one for each country.
结局指标
主要结局
Fertility
时间窗: through study completion, an average of 1 year
Rate of infertility and number of pregnancies. Number of attempts to achieve pregnancy.
Pregnancy
时间窗: through study completion, an average of 1 year
Rate of successful pregnancies. Number of miscarriages.
次要结局
- Complications, medical(through study completion, an average of 1 year)
- Surgical approach(through study completion, an average of 1 year)
- Abortion/s(through study completion, an average of 1 year)
- In-vitro fertilization(through study completion, an average of 1 year)
- Complications, surgical(through study completion, an average of 1 year)
研究者
Gianluca Pellino
Lecturer
University of Campania "Luigi Vanvitelli"